NCT05674981Completed
To Evaluate the Beneficial Effect of Probiotics on DKD Patients and the Role of Gut Microbiota Modulation
To Evaluate the Clinical Efficacy of Probiotic in Patients With DKD
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
To evaluate the efficacy of probiotics in the treatment of diabetic kidney disease, this study is designed to explore after consumption of probiotics lactobacillus reuteri ADR-1 and lactobacillus rhamnosus GM-020 composite strain powder sachets for 6 months, whether the improvement of blood sugar, kidney related indicators can further improve the course of diabetic kidney disease. The clinical trial predicted that probiotics can improve diabetic kidney disease by changing the intestinal flora by inhibiting harmful bacteria, reduction of systemic oxidative stress, balance carbohydrate and fat metabolism, further preventing the progress of diabetic kidney disease.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 19 Dec 2022
- Start date
- 24 Apr 2023
- Primary completion date
- 24 Apr 2025
- Lead sponsor
- GenMont Biotech Incorporation
- Diseases
- Chronic kidney disease
- NCT number
- NCT05674981
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 24 Apr 2023 to the primary completion date, 24 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking immunosuppressive drug, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers in past 3 months
Other illness
- Patients with Type I Diabetes Mellitus
- Patients with inflammatory bowel disease, liver disease, liver cirrhosis, systemic lupus erythematosus, malignancy, and high blood pressure.
- Patients with hypoglycemic coma, Diabetic ketoacidosis, hyperosmolar non-ketotic diabetic coma, or diabetes mellitus acute complications.
- Acute infection medical history in past 3 month
Lab values
- Fasting blood glucose \>13.3 mmol/L
Other
- GPT\>100U/L (2.5 times than usual situation)
- Vulnerable population (Including breeding or pregnant women, prisoner, aboriginal, disabled population)
- Smoker or Alcoholic
- Taking Antibiotics in past 1 month
- Stably taking probiotics supplements in past 1 months (Yogurt or dairy products were excluded)
Who the study is looking for
- Age between 25 and 80 years old
- Suffering from type 2 diabetes and stable medication for 3 months
- Detection of HbA1c before meals between 7% and 10%
- Stage 1-3a diabetic nephropathies (eGFR \> 45 mL/min)
- Microalbuminuria estimated between 30 to 300 mg/day
Age in the registry: 25 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chung Shan Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.